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Trial record 1 of 1 for:    NCT01973179
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Re-irradiation of Recurrent Head and Neck Cancer (ReKo)

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ClinicalTrials.gov Identifier: NCT01973179
Recruitment Status : Recruiting
First Posted : October 31, 2013
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Mechthild Krause, Technische Universität Dresden

Tracking Information
First Submitted Date October 25, 2013
First Posted Date October 31, 2013
Last Update Posted Date March 9, 2021
Study Start Date July 2015
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 25, 2013)
late toxicity [ Time Frame: 24 months after therapy ]
measured from the first day of treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 25, 2013)
  • acute toxicity [ Time Frame: 3 months after treatment ]
    measured from the first day of treatment
  • local recurrence free survival [ Time Frame: 24 months after therapy ]
    measured from the first day of treatment
  • overall survival [ Time Frame: 24 months after therapy ]
    measured from the first day of treatment
  • quality of life [ Time Frame: 24 months after therapy ]
    measured from the first day of treatment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Re-irradiation of Recurrent Head and Neck Cancer
Official Title Observational Study to Re-irradiation for Recurrent Head and Neck Cancer
Brief Summary

The goal of this observational study is to evaluate the toxicity and local tumor control of proton therapy for patients with head and neck cancer in a previously irradiated field.

Standard of care for recurrent or secondary malignancies in a previously irradiated field is surgery. For inoperable patients or residual tumor after surgery, standard of care would be palliative chemotherapy. For a small subset of patients (good performance status, small radiation fields) re-irradiation can be performed. In this study the established concept of re-irradiation with photons will be transferred to proton radiotherapy. Proton therapy has the advantage of a steeper dose gradient to normal tissues, thus-theoretical advantages for lower toxicity.

Detailed Description

OBJECTIVES:

Primary: Evaluation of late toxicity of re-irradiation with protons, for patients with head and neck cancer in a previously (> 50 Gy) irradiated field.

Secondary: Evaluation of the efficacy (local control) and acute toxicity (after 24 Months) of re-irradiation with protons up to a dose of 60 Gy, for patients with head and neck cancer in a previously (> 50 Gy) irradiated field.

OUTLINE This is a single center observational study. In-house standard of care for patients (good performance status and with small tumors) with head and neck cancer in a previously (> 50 Gy) irradiated field is to irradiate the tumor with a hyperfractionated schedule and concurrent cisplatin up to a dose of 66 Gy. Dose limiting for this schedule is the incidence of acute and late toxicity induced by radiation. The purpose of the study is the evaluation of the safety of a treatment schedule based on the use of protons.

Proton beam treatments will be delivered in 2 Gy fractions, 5 days per week, to a total dose of 60-66 Gy equivalent.

Study visits are performed:

During proton therapy once per week. Follow-up visits are scheduled every 3 months for the first 24 months after proton therapy.

Primary endpoint is late toxicity 24 months after proton treatment.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a recurrent or secondary head and neck carcinoma
Condition Head-and-neck Carcinoma
Intervention Radiation: Radiation therapy
Radiation therapy with protons
Study Groups/Cohorts Radiation therapy
Radiotherapy with protons in patients with head and neck carcinoma
Intervention: Radiation: Radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 25, 2013)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2023
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • tumor is located in a previously irradiated area with at least 50 Gy or there is an overlap of radiation fields with resulting total doses greater than 90 Gy to expect
  • tumor size and localization allow high dose re-irradiation (individual decision)
  • exclusion of distant metastases
  • Time interval between pre-irradiation and re- irradiation at least 1 year for local recurrence; at least 6 months for secondary tumor disease
  • age ≥ 18 years
  • previous radiotherapy treatment plans available
  • pre-treatment imaging (pre re-irradiation) available
  • good general condition (ECOG 0-1)
  • dental treatment performed, if necessary
  • in case of surgery before re-irradiation: resection status is R-1 or R-2
  • clinical suspicion of residual tumor by very scarce surgical margins (<1 mm)
  • pathological secured extracapsular extension (ECE)
  • indications by an interdisciplinary tumor board
  • patient able to understand the intention and procedures of the trial, written informed consent

Exclusion Criteria:

  • no description of the R- status after resection of the tumour
  • pregnancy
  • no written informed consent
  • distant metastases
  • interval between first and second irradiation < 6 months at secondary tumor or <1 year when local recurrence of previously irradiated tumor
  • simultaneous participation in another intervention study , if further treatment must be carried out
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Mechthild Krause, Prof. Mechthild.Krause@uniklinikum-dresden.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01973179
Other Study ID Numbers STR-ReKo-2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Mechthild Krause, Technische Universität Dresden
Study Sponsor Technische Universität Dresden
Collaborators Not Provided
Investigators
Study Chair: Mechthild Krause, Prof. Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
PRS Account Technische Universität Dresden
Verification Date March 2021